Technical Field
This application generally relates to qualification protocols.
Description of Related Art
Different scientific instruments may be included in a laboratory. Such scientific instruments may include mass spectrometers (MS), instruments performing a chromatographic separation such as gas chromatographs (GC) and liquid chromatographs (LC), and the like. Operation of such instruments may be controlled using a computer system directly connected to one or more of the instruments. For example, a computer system may be used to control operation of an LC and an MS to obtain mass spectral data for a sample. The computer system may also be used in connection with performing further processing and analysis of the data, such as the mass spectra, acquired using the instruments. The data acquired from the instruments (such as raw data acquired from the instruments prior to subsequent analysis processing) as well as additional data analysis information may be stored on data storage devices of the computer system. Users may log on to the computer system with account names and passwords for authentication. Such authentication may be required prior to allowing a user to operate the instruments and also utilize software on the computer system to perform subsequent data processing and analysis of the data acquired using the instruments.
The foregoing system including the instruments and computer may be used to analyze various products and samples such as, for example, in connection with products developed by pharmaceutical companies and testing samples in hospitals and governmental laboratories. The systems performing this analysis may be regulated and required to be compliant with certain standards, guidelines, and/or regulations covering a wide variety of items. For example, the use of scientific instruments may be required to comply with government regulations for instrument qualification and validation for the same throughout the lifecycle of such instruments and other devices in a system.